Journal
BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION
Volume 26, Issue 5, Pages 884-892Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.bbmt.2019.12.763
Keywords
Acute myeloid leukemia; Gemtuzumab ozogamicin; Hematopoietic cell transplantation; Sinusoidal obstruction syndrome; Veno-occlusive disease
Categories
Funding
- Pfizer
- National Cancer Institute (NCI) [U24CA076518]
- National Heart, Lung, and Blood Institute (NHLBI)
- National Institute of Allergy and Infectious Diseases
- NHLBI [U24HL138660, R01HL131731, R01HL126589, OT3HL147741, R21HL140314, U01HL128568]
- NCI
- NCI [U24CA233032]
- Health Resources and Services Administration (HRSA) [HHSH250201700006C]
- Office of Naval Research [N00014-18-1-2888, N0001417-1-2850]
- HRSA [SC1MC31881-01-00]
- National Institutes of Health [5P01CA111412, 5R01HL129472, R01CA152108, 1R01HL131731, 1U01AI126612, 1R01CA231141]
- Actinium Pharmaceuticals, Inc.
- Adaptive Biotechnologies
- Allovir, Inc.
- Amgen, Inc.
- Anthem, Inc.
- Astellas Pharma US
- Atara Biotherapeutics, Inc.
- BARDA
- Be the Match Foundation
- bluebird bio, Inc.
- Boston Children's Hospital
- Bristol Myers Squibb Co.
- Celgene Corp.
- Children's Hospital of Los Angeles
- Chimerix, Inc.
- City of HopeMedical Center
- CSL Behring
- CytoSen Therapeutics, Inc.
- Daiichi Sankyo Co., Ltd.
- Dana Farber Cancer Institute
- Enterprise Science and Computing, Inc.
- Fred Hutchinson Cancer Research Cente
- Gamida-Cell, Ltd.
- Genzyme
- Gilead Sciences, Inc.
- GlaxoSmithKline
- HistoGenetics, Inc.
- Immucor
- Incyte Corporation
- Janssen Biotech, Inc.
- Janssen Pharmaceuticals, Inc.
- Janssen Research & Development, LLC
- Janssen Scientific Affairs, LLC
- Japan Hematopoietic Cell Transplantation Data Center
- Jazz Pharmaceuticals, Inc.
- Karius, Inc.
- Karyopharm Therapeutics, Inc.
- Kite, a Gilead Company
- Kyowa Kirin
- Magenta Therapeutics
- Mayo Clinic
- Medac GmbH
- Mediware
- Memorial Sloan Kettering Cancer Center
- Merck Company, Inc.
- Mesoblast
- MesoScale Diagnostics, Inc.
- Millennium, the Takeda Oncology Co.
- Miltenyi Biotec, Inc.
- Mundipharma EDO
- National Marrow Donor Program
- Novartis Oncology
- Novartis Pharmaceuticals Corporation
- Omeros Corporation
- Oncoimmune, Inc.
- OptumHealth
- Orca Biosystems, Inc.
- PCORI
- Pfizer, Inc.
- Phamacyclics, LLC
- PIRCHE AG
- Regeneron Pharmaceuticals, Inc.
- REGiMMUNE Corp.
- Sanofi Genzyme
- Seattle Genetics
- Shire
- Sobi, Inc.
- Spectrum Pharmaceuticals, Inc.
- St. Baldrick's Foundation
- Swedish Orphan Biovitrum, Inc.
- Takeda Oncology
- The Medical College of Wisconsin
- University of Minnesota
- University of Pittsburgh
- University of Texas-MD Anderson
- University of Wisconsin-Madison
- Viracor Eurofins
- Xenikos BV
- Foundation Rochester
Ask authors/readers for more resources
Gemtuzumab ozogamicin (GO) therapy before allogeneic hematopoietic cell transplantation (alloHCT) has been historically associated with an increased risk of hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) in patients with acute myeloid leukemia (AML). The current analysis examined VOD/SOS risk and outcomes in a cohort of patients who in recent years were reported to the Center for International Blood and Marrow Transplant Research. Adults with AML who had GO exposure before myeloablative alloHCT were matched 1:4 by age and disease status at transplant to recipients without GO exposure (control subjects). One hundred thirty-seven patients with GO exposure and 548 matched control subjects who underwent alloHCT between 2008 and 2011 were included in this analysis. With a median similar to 8-year follow-up of survivors, the 5-year overall survival probability was similar in the 2 cohorts: 38% and 38% in the GO-exposed versus control groups (P = .97). Incidence of VOD/SOS and severe VOD/SOS, respectively, at 100 days was 4% (95% confidence interval [CI], 1% to 7%) and 3% (95% CI, 1% to 6%) in GO-exposed patients and 3% (95% CI, 2% to 5%) and 1% (95% CI, 0% to 2%) in control subjects. Correspondingly, among patients who developed VOD/SOS, 1-year survival probability after VOD/SOS diagnosis was 33% (95% CI, 5% to 72%) and 27% (95% CI, 11% to 47%; P = .78). In multivariate analyses, GO exposure before alloHCT was not associated with an increased risk of VOD/SOS (odds ratio, 1.10; P = .85) or death (hazard ratio, 1.08; P = .57). Three deaths (3%) in the GO group and 3 deaths (<1%) in the control group were attributed to VOD/SOS. Our results suggest that GO treatment before myeloablative alloHCT in the recent era is not associated with an increased risk of post-transplant VOD/SOS or death. (C) 2019 American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc.
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